GOVERNMENT & POLICY GATEWAY Entrance to Fort Detrick, home to the new National Interagency Biodefense Campus.
TESTING THE LIMITS Biodefense research to characterize threats may violate the biological weapons treaty, experts say LOIS R. E M B E R , C&EN W A S H I N G T O N
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ality But arms control experts say the Department of Homeland Security (DHS) is failing to consider this as the agency develops a research agenda for its National Biodefense Analysis & Countermeasures Center. Of particular concern to these experts is the work being planned for NBACC's Biological Threat Characterization Center (BTTC), work that may or may appear to violate the Biological Weapons Convention. Article I of the treaty states that nations adhering to it are never to "develop, produce, stockpile, or otherwise acquire or retain ... biological agents or toxins... of types and in quantities that have no justification for prophylactic, protective, or other peaceful purposes." It also bans delivery systems designed to use such agents or toxins for hostile purposes. It's been difficult to judge how NBACC's research plays out against the backdrop
of the treaty's strictures. Like shapeshifters, NBACC's organization and its research agenda keep changing and being redefined. The research plan has variously been characterized as a work in progress, a bit notional, and a shifting landscape. Gerald L. Epstein, senior fellow for science and security at the Center for Strategic & International Studies, says that's "because we don't know the full set of questions that have to be answered," making it difficult to set priorities, protocols, and approaches. Epstein is correct. But Alan Pearson, director of the Biological & Chemical Weapons Control Program at the Center for Arms Control & Non-Proliferation, says D H S officials "have not carefully thought through what work is needed in the biothreat area and are working from a Cold War model." And "combined with the current gospel that high school students can create biological weapons, that raises my concerns," he adds.
W h e t h e r NBACC research—especially in the threat characterization arena—ends up circumventing the treaty or is merely perceived to be doing so maybe moot. Arms control policy analysts argue that either could lead to the same end point: a renewed biological arms race. As Jonathan B. Tucker, senior researcher at Monterey Institute of International Studies' Center for Nonproliferation Studies, explains, some work at B T T C could "give other countries a license to do offensive research under the pretext of biodefense." At least four NATO allies are aware of the types of research NBACC is considering undertaking. But if the research ends up being classified—and independent analysts believe most of it will—"this could raise concerns among other countries about our intentions. Even if the research is complying with the treaty how will they know that?" Tucker asks. A government official familiar with NBACC's plans thinks DHS officials "are probably not sufficiently sensitive to the concerns of other countries. The issue of the U.S. biodefense program and whether certain aspects of it may go over the line is a live issue in these countries." WHAT ESPECIALLY piqued the chagrin of experts was last year's widely circulated description of proposed work that they fear could breach the 33-year-old treaty or give the appearance of contravening it. They maintain that even the perception ofviolation is sufficient to weaken this bulwark against the use of biological weapons agents and diminish, not enhance, national security NBACC is DHS's first in-house laboratory to focus on biodefense—part of a wider government response to the terror attacks of Sept. 11,2001, and the anthrax mailings that followed. U.S. concerns about and efforts to counter bioterrorism began in the mid-1990s during the Clinton Administration. But the 2001 autumn of terror catapulted biodefense to the forefront of the Bush Administration policy agenda. Since 2001, the US. has ramped up
NBACC's organization and its research agenda keep changing and being redefined. "We don't know the full set of questions that have to be answered/' 26
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spending on civilian biodefense 18-fold: from $414 million in 2001 to $7.6 billion in 2005. The 2005 figure includes a onetime appropriation of $2.5 billion for Bioshield, a program to acquire therapeutic countermeasures. For 2006, the Bush Administration has requested $5.1 billion, which will bring the total for biodefense over a five-year span to about $28 billion. "A lot of money is now being spent on biodefense, and it's not money being spent from a well-informed strategic perspective," says Michael L. Moodie, president of the Chemical & Biological Arms Control Institute. "There's got to be a more strategic approach to biodefense R&D," he insists. Tara OToole, CEO and director of the Center for Biosecurity of the University of Pittsburgh Medical Center, heartily agrees. NBACC's "mission should definitely be part of a broad U.S. biosecurity strategy that lays out the R&D needed to ensure we could survive deliberate bioattacks or largescale natural epidemics and, at the same time, protect U.S. preeminence in bioscience and defend against strategic technological surprise." The absence of "a strategic view makes it difficult to weigh options and priorities," O'Toole explains. This void, she says, increases the "likelihood ofwasteful overlap and gaps in what we are doing for biodefense/biosecurity" The prime motivating force behind the Administration's biodefense push is the astounding advances in biology and biotechnology, particularly in genetic engineering, genomics, proteomics, and pathogenesis. Pathogenicity studies tease out the biochemical basis of how microbes cause disease. U.S. officials fear that if the steep trajectory of advances continues, hostile states and, especially, terrorists could acquire the tools to build better bugs—bugs that are more lethal, more environmentally stable, more difficult to detect, and more resistant to existing drugs and vaccines than nature's offerings. Because of this apprehension, governm e n t officials and others argue that NBACC's threat characterization research is especially needed. David R. Franz, vice president and chief biological scientist at Midwest Research Institute, ticks off three reasons: "It's so difficult to get good intelligence. People and equipment are dual use. Relevant technologies and scientists with appropriate expertise have proliferated beyond the U.S." Franz once commanded the U.S. Army Medical WWW.CEN-0N
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Research Institute of Infectious Diseases (USAMRIID) andnow advises DHS's Science & Technology Directorate, which manages NBACC. To rationalize its expansive biodefense program, US. officials cite the attempts of the Japanese sect Aum Shinrikyo to use anthrax, as well as the Soviet Union's massive biological weapons program and Iraq's much smaller one that was dismantled by United Nations inspectors. Often not mentioned is that the attacks throughout the 1990s and up to the present—includ-
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ing those on Sept. 11—were launched by international terrorists using bombs or planes, not bugs. Most experts believe the anthrax attacks were perpetrated by someone who came out of a U.S. military lab, not an international terrorist. Also often slighted is this vexing fact: The classical biological weapons agents such as anthrax and smallpox— forget genetically altered microbes—are not easily produced in a form that can be disseminated effectively and safely and, especially, without infecting the users themselves. Aum Shinrikyo's several failed attempts to release a lethal strain of anthrax underscore the difficulties. This group had the money, scientists, equipment, and labs to develop anthrax without being detected. There is no evidence, at least none that has been made public, that current terrorist groups have the resources needed to mount a large attack with classical, let alone bioengineered, bugs. Still, NBACC is a Bush Administration response to the possibility that terrorists might be able to do so. IN ADDITION to a National Bioforensic Analysis Center, NBACC will also house BTTC and an affiliated Biodefense Knowledge Center now located at the Energy Department's Lawrence Livermore National Lab, dubbed NBACC West.
B T T C , whose proposed research raised the hackles of arms control experts, will concentrate on what the Administration calls "science-based threat assessment." DHS is directed by the Homeland Security Act of 2 0 0 2 and the April 2 0 0 4 presidential directive Biodefense for the 21st Century to conduct research to understand current and future biological threats in order to develop appropriate countermeasures. BTTC's mission is one of early warning: "to get an early sense of both U.S. vulner-
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abilities and how we might expect bugs to react if launched against the U.S.," Franz explains. In short, the center is charged with filling knowledge gaps for such highconsequence biological agents as smallpox, as well as bioengineered microbes, by assessing vulnerabilities and determining likely consequences. In practice, arms control experts fear that in fulfilling its mission to anticipate and prevent biological attacks, B T T C may cross the line from treaty-permissible defensive research to treaty-barring offensive research. Maureen I. McCarthy—who hails from the Department of Energy, where she directed its National Nuclear Security Administration and who now directs the Office of Research & Development within DHS's Science & Technology Directorate (C&EN, Sept. 29,2003,page ^ - s t r e s s es that BTTC "is not a research program." Rather, she says, it is "a very targeted, intelligence-driven effort that looks at specific areas that are of concern to the national biodefense strategy" She emphasizes that "everything we do is for defensive purposes. Completely Entirely We are not in the business of developing weapons." And Franz supports her. "I am coming from the fundamental and absolute belief that there is no intent to produce biological weapons," he says. C&EN
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GOVERNMENT & POLICY Mark L. Wheelis, a microbiologist and arms control expert at the University of California, Davis, offers a more nuanced response. The potential exists for the development of a "short-notice offensive capability" if BTTC carries out the full spectrum of proposed research suggested in the controversial presentation that provoked consternation last year, he says. The full gamut of proposed research, carried out with "a protective intention and no intent to resume biological weapons production," would nevertheless allow the U.S. to develop "a range of new genetically engineered pathogens, new production capabilities suitable for covert production ofbiological weapons agents, new methods of dissemination, and new ways of extending the longevity of pathogens in the environment," Wheelis argues. "I don't think that's what we're trying to do," Wheelis says. "But there are many nations, including many we count as friends, that are less confident of our benign intentions than I am." BTTC's purpose, McCarthy counters, is to understand the potential capabilities of an adversary to launch attacks. "Most important," she says, the center's raison d'être is "to understand the efficacy of our countermeasures." BTTC is being asked to help develop countermeasures not only against classical agents but also against future biological threats. But, Epstein explains, saying research will be undertaken "to resolve scientific uncertainty involving future biological threats causes some people to leap to the conclusion that means the development of novel pathogens." Of concern USDA Plant Pathogen Research
is that such manipulated pathogens could express traits that disable or evade existing defenses. Gerald W. Parker, director of DHS's Office of Science-Based Threat Analysis & Countermeasures, insists, "We are not doing research to develop novel, new ways to package microbes that would make them more efficient for dissemination for intentional purposes." But Parker, who formerly headed the U.S. Army Medical Research & Materiel C o m m a n d , told a r e p o r t e r for the newsletter CQHomelandSecurity last fall, "if there is a clear indication that we are faced with a real potential of a genetically engineered {novel} pathogen... that we don't understand ... we have to leave open the possibility we may need to replicate that {pathogen}." "The point isn't that we're going to conduct research that will enhance the offensive capabilities of the U.S.," says arms control expert Matthew S. Meselson, a molecular biologist at Harvard University Rather, "we could have a program designed by people who are not sensitive to arms control issues, the likelihood of copycats, and the spread of these things around the world," he adds. The program designers need the "sensitivity to know when enough is enough or if what they plan to do is really worth the risks imposed." Many arms control experts fear the lack of such sensitivity. Adding to their concerns is NBACC's prevailing culture, a legacy of its history NBACC was created in the Department of Defense, possibly at the Armed Forces Medical Intelligence Center, and transferred to D H S by the
Homeland Security Act of 2002. DHS officials now overseeing NBACC or managing its component centers come from the defense and intelligence communities, leading some critics and even some government officials to bemoan their lack of public health orientation. IN FACT ρ this plays into a broader, governmentwide philosophical debate "be tween the public health community and the security community on how to ap proach biodefense and biosecurity," Pear son says. He believes that DHS, whose "outlook is more informed by security per spectives," also "needs to consider public health aspects" of a potential bioattack. Such consideration, he contends, will bring about more openness, more transparency, and more sharing of vital information. Even where NBACC is to be built re flects its origin. DHS's $130 million facil ity will be part of a 200-acre National In teragency Biodefense Campus at Fort Detrick in Frederick, Md. DHS hopes to reap the rewards of synergy by locating NBACC at the Army garrison in proxim ity to USAMRIID, the National Institute of Allergy & Infectious Diseases' inte grated research facility, and the Depart ment of Agriculture's plant pathogen re search facility Groundbreaking for the 160,00 0-sqft facility is slated for summer 2 0 0 6 . About 70,000 sq ft will be devoted to lab oratory space, of which about 20% will be BSL-4—or maximum containmentlabs able to handle pathogens for which there are no treatments or cures. About 120 researchers and support staffwill work
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N E W K I D National Interagency Biodefense Campus at Fort Detrick, in Maryland, will soon include the National Biodefense Analysis & Countermeasures Center. An artist's rendition of the building is shown above.
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at NBACC when the facility is completed in summer 2008. McCarthy notes that despite the lack of a bricks-and-mortar building, some NBACC work is already being conducted. T h e bioforensic center is charged with conducting analyses of biocrime evidence or a terrorist attack to finger perpetrators and determine the origin and method of attack. This center has established a partnership with the Federal Bureau of Investigation and is already doing casework in lab space borrowed fromUSAMRIID. The knowledge center at Livermore "is working very closely with the threat characterization program," McCarthy says. The center analyzes information from intelligence and other sources that help shape and inform the threat characterization program. According to McCarthy, "There's a lot ofwork going on through the threat characterization program that doesn't actually involve doing lab work." Currently, she says, most involves "understanding what the threat is" and "developing knowledge, information, and products." Such products include material threat assessments of specific biological agents, ranked in order of risk and potential impacts on the U.S., that will support the biodefense efforts of D H S and other agencies. For example, these assessments will aid the Department of Health & Human Services' decision-making on which drugs and vaccines to acquire under Bioshield, and on "prioritization of its research programs," McCarthy explains. One of BTTC's "biggest programs" is developing "a comprehensive risk assessment methodology" called for in Biodefense for the 21st Century, McCarthy says. BTTC's work is part of a larger interagency effort, as she explains, "to put scientific rigor behind the risk assessment methodology" to better understand the biothreat. McCarthy says some "very specific and tailored" threat characterization research is being carried out at private and government labs, including at USAMRIID, the Centers for Disease Control & Prevention (CDC), Lovelace Respiratory Research Institute in Albuquerque, Battelle Memorial Institute, and DHS's University Centers of Excellence. McCarthy cites pathogenicity studies of classical biological agents, studies of "different types of materials that have been studied extensively," as now being investigated. "We are looking at countermeasure effectiveness, at the virulence of WWW.CEN-0NLINE.ORG
certain types of agents in different types of animal models, and we are also looking at understanding how different types of pathogens may affect the civilian population at risk." What troubles the arms control experts is not so much the research McCarthy mentions but rather the types of research projects that then-deputy NBACC di-
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rector George W. Korch Jr. unveiled in February 2004 to a Pentagon workshop on pest management held in Florida. In his PowerPoint presentation (www.cbw transparency.org/archive/nbacc.pdf), Korch listed 16 subject areas that he said BTTC planned to study Found among the 16 are susceptibility to current therapeutics; aerosol dynamics; novel delivery; novel packaging; environmental stability; bioregulators and immunomodulators; genomic s/proteomics/transcript; and red teaming, the computer or lab duplication of threat possibilities. Korch also summarized what he called "task areas" for assessing biothreat agents and for technical threat assessment. His task-area sequence—acquire, grow, modify, store, stabilize, package, and disperse—would be used to characterize the threat potential of classical, emerging, and bioengineered pathogens. The aerobiology, aerosol physics, and environmental stability of agents would be studied by computer modeling and in wet labs. Computer modeling "of feasibility, methods, and scale of production" would also be tackled. The Korch presentation prompted a concise but powerful response expressing concerns that some of NBACC's proposed research might run afoul of the treaty's constraints. The three authors of the commentary published in May 2 0 0 4 in Politics & the Life Science are no lightweights on the subject: Milton Leitenberg is a senior research scholar and biowarfare expert at the University of Maryland.
James Leonard, as ambassador, led the U.S. delegation to the Biological Weapons Convention negotiations in 1972. And Richard Spertzel, a former deputy director of USAMRIID, served as senior biologist on the staff of the first U N inspection group investigating Iraq's weapons. According to the authors, coupling the task areas with computer modeling "of feasibility, methods, and scale of production" studies "may constitute develo p m e n t in the guise of threat assessment, and they certainly will be interpreted that way" Development, they point out, is banned by the treaty T h e commentary was the proverbial shot across the bow and, according to several sources, caught Korch and D H S by surprise. It also provoked a defensive, tight-lipped posture from DHS officials—a posture that remains in place to this day, a government analyst says. The commentary poses the question: "Will all the work in the categories listed ... be classified, carried out under conditions of secrecy, or will it be open, generating peer-reviewed publication?" Both McCarthy and Parker say NBACC will publish as much as possible in the open literature and only if research reveals US. vulnerabilities will it be classified. But Leitenberg says highly placed sources have told him that "all threat assessment research will be classified." "I'm frankly not hysterical about classification," Leitenberg says. "I am frightened about the compliance question. If classification is the means ofnoncompliance, then it's a problem." "THE PROBLEM/' Epstein explains, "is the treaty doesn't have clear, objective criteria of what types of activities are or are not in compliance, and so people may disagree on the compliance of any specific activity The treaty doesn't mention research, only development. So when does research slip into development" and over the line? he asks. To illustrate the difficulty Epstein and others point to three clandestine threat assessment projects—Jefferson, Clear Vision, and Bacchus—conducted by the Clinton Administration's Defense Department and intelligence community Although Administration officials claimed the three were permissible under the treaty, arms C&EN
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GOVERNMENT & POLICY control experts and legal scholars contin ue to differ on the legality of two projects; however, most judge Project Clear Vision as clearly having crossed the line. The aim of Clear Vision—a project car ried out by Battelle Memorial Institute un der contract to the Central Intelligence Agency—was to assess agent dispersal characteristics of a Soviet-designed "bomblet."To do so, Battelle—the same institute now doing threat characteriza tion research for NBACC—built and test ed a bomblet, which the experts deemed a delivery system and, therefore, barred by the treaty Arms control experts, like Leitenberg, see shades of these three black-box proj ects in NBACC's research plans. Secrecy notwithstanding, two other DHS actions have added to Leitenberg's consternation. In April, DHS proposed to make the NBACC facility a Federally Funded Re search & Development Center (FFRDC), a sort of government-owned, contractoroperated arrangement. According to Mc Carthy, making NBACC a FFRDC "is the best way for us to manage this program"
and "to recruit the best and brightest peo ple." She adds, "The model we are basing it on is how the national labs work." There are currently some 37 existing FFRDCs and a Congressional Research Service report says, "Many FFRDCs con duct research principally in classified fields for the defense and intelligence commu nities." Leitenberg says that "it can prob ably be assumed" the conversion of NBACC into an FFRDC "will make over sight of its work significantly more difficult than it would otherwise have been." The second action troubling Leitenberg is DHS's adoption ofwhat he terms a "nov el interpretation of the provisions ofArti cle I" of the treaty In the draft and final En vironmental Impact Statements for the NBACC facility and in itsfiscal2006 Con gressional justification for the facility DHS inserted the word "offensive" in its expla nation of Article I. In the three documents, DHS insists research at NBACC would be for defen sive purposes only and would be compliant with the treaty But DHS goes on to state that the treaty "prohibits the development,
production, stockpiling, and acquisition of offensive biological weapons." DHS's interpretation implies that the treaty allows the development, produc tion, and stockpiling of defensive biologi cal weapons, which it does not. In fact, says Penrose (Parney) Albright, formerly an as sistant DHS secretary for science and tech nology responsible for setting policy and al locating NBACC's budget: "I am unaware of anything that might be called a defen sive biological weapon. The qualification is tautological." At any rate, the treaty makes no dis tinction between offensive and defensive weapons. Some policy analysts speculate that the word was inserted to create more room for studies DHS wants to do. Leitenberg contends the insertion of the word "was deliberate" and flies in the face "of all existing international legal in terpretations." Furthermore, he finds the pairing ofNBACC's research with the reinterpretation of the treaty "very troubling." Three inquiries to DHS by the Cen ter for Arms Control & Non-Proliferation seeking an explanation for the in-
I N T E N T I O N S
Parsing The Bioweapons Treaty
T
he language of the Biological Weapons Convention, especially its pivotal Article I, is not clear-cut. It doesn't draw a bright line between activ ities that are permitted and those that are prohibited. So compliance with the treaty turns to a great extent on the intent of the activity.
Bush Administration officials, including those in the Department of Homeland Security, insist that the govern ment's biodefense ac tivities will be for defen sive purposes, which the treaty permits. For the Administration, compli ance with the treaty is based on the intent of Fidler the activity. By its rea soning, if the activity's intent is to protect the civilian population against a terrorist act, then the activity is defensive and in compliance with the treaty. "The problem," explains David P. Fidler, professor of law at Indiana Uni versity, "is that intent becomes an easy
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way to justify anything." And, he points out, the defensive intent approach adopt ed by the Administration allows it to in crease its policy options. "A lot of people want to use the defensive intent argu ment to minimize the treaty's effect on U.S. biodefense activities in a legal and policy sense," he says. &Z fia ^:ψ^
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Fidler proposes that, in this new w o r l d of t e r r o r ism, policymakers move away f r o m considering compliance in t e r m s of defensive intent and in stead adopt a more stra * e g i c conception of i n ternational law. By that,
he means policymakers should begin to consider whether an activity—de velopment or retention of an agent, for example—is justified on the basis of prophylactic, protective, or peaceful purposes—the three ρ words found in Article I. He believes that if policymakers move beyond intent and "if the compliance process is transparent and there is po
litical accountability and oversight, then you have biodefense activities moving forward in a context that seems to be more legitimate." Fidler readily admits that his ap proach w i l l not make it any easier to de termine compliance, but it might rein in the activities pursued. "I'm concerned that increases in biodefense activities are going to create proliferation dangers because of the inadequacy of biosecurity measures nationally and internationally."
A R T I C L E I OF T H E BIOLOGICAL WEAPONS CONVENTION Each state party to the Convention under takes never in any circumstances to devel op, produce, stockpile, or otherwise ac quire or retain: (1) Microbial or other biological agents or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective, or other peaceful purposes; (2) Weapons, equipment, or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.
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terpretation have been rebuffed. W h e n C&EN asked McCarthy what DHS intended, she responded: "I told you what the intent is. We are not developing weapons." Parker echoed her statement. But neither explained why the word was inserted or why it hasn't been removed after arms control and legal experts pointed out the implications. "People at DHS truly believe their intent is good, but they have a very difficult time understanding how other people might have suspicions," explains Pearson, who as a D H S science fellow worked in the Program, Plans & Budget Directorate overseeing NBACC's programs. "They feel the assertion of benign intent is sufficient." Still, McCarthy and Parker attempt to negate the criticisms of the commentary authors by saying that Korch's presentation has been misinterpreted and, even more to the point, what he described has since been superseded by a different research agenda. McCarthy also contends that Korch's briefing "was actually given before DHS was even stood up," which is not correct. Addressing Korch's task-area sequence from acquire to disperse, McCarthy says: "What the presentation was trying to explain are those steps an adversary would have to take in order to execute an attack. Those are steps that go on between someone thinking they want to do something to actually having a massive impact on the U.S. civilian population." She sidestepped the question of whether the sequence referred to computer simulation or wet-lab research by saying, "We will do everything that is necessary to ensure that the biodefense strategy for this country protects the U.S. people." D H S is concerned about those microbes that have the potential to cause "catastrophic, mass casualty events," Parker says. Korch's sequence was a way of thinking through—in what Parker terms "nonlaboratory-based studies"—the steps an adversary would have to take from acquiring mass-casualty-producing pathogens to actually delivering them. "They are not categories of research that we are pursuing. They are concepts to consider to better understand how an adversary would use a microbe as a weapon." Leitenberg says Parker's explanation "is impossible to reconcile with the details of Korch's briefing." Korch's task areas "are phrased so as to imply laboratory studies, and in one case explicitly states 'wet lab.' " "I see no reason to assume that Korch's WWW.CEN-ON LINE.ORG
description of the NBACC research program should not continue to be considered as accurate and valid until there is an official U.S. government statement" disavowing it, Leitenberg adds. In contrast to Korch's briefing, Parker offers NBACC's current plans, which, he says, will initially focus on nonlab-based studies as part of the risk assessment process and material threat assessments. Lab work on classical agents at the BTTC center "will increase as we better understand what our critical knowledge gaps are that require us to go to the lab to address," he explains. The lab studies, he says, will be "specific" and "targeted." Some categories of research that "we would anticipate we would need to work on may include applied—not basic—pathogenesis." As an example of an "applied pathogenesis" study, Parker cites "comparative oral and aerosol lethality," which Leitenberg points out is basic pathogenesis. Korch's briefing listed basic pathogenesis as a planned capability of BTTC. "Studying the mechanisms of pathogenesis can get sensitive," Pearson says. "It can lead to improved countermeasures, but it can also lead to improved weapons." Parker says BTTC will study the virulence of microbes, possibly doing "comparative studies on the phenotypic and genotypic expression of virulence." Other studies may focus on the lethality, infectivity, toxicity, and transmissibility of microbes, and "some of that may be validation of work that is old," he says. Still other research may study a microbe's "resistance to countermeasures to include medical, detection, or even decontamination." All these studies will be conducted in animal models in a controlled laboratory environment, he says.
Given its mission statement, B T T C will eventually have to study genetically engineered organisms to test current countermeasures or to develop new ones. The questions then become: Which of the myriad microbes do you manipulate,
Everything we do is for defensive purposes. Completely. Entirely. We are not in the business of developing weapons."
TO HIS LIST of research categories, Parker adds studies on the growth characteristics of various pathogens under different environmental conditions and on different media. He admits that most of this information is already available; however, he says, some of it may have to be revalidated. Understanding the growth characteristics of a pathogen allows one to predict whether "an adversary could produce it on a large enough scale with a given toxicity or lethality to enable it to cause a desired mass-casualty effect," he explains. Research under Parker's broad categories will be conducted on classical threat agents—CDC's Category A agents, also called select agents. "That's our priority right now," he says.
and how do you keep the altered organisms out of the hands of terrorists once they're made? However the research agenda is eventually structured, NBACC officials will need to take steps to reassure other nations, especially US. allies, that the research complies with the treaty "The government's 'trust us' is not good enough," Moodie says. Pearson agrees and argues that transparency has to be increased. As he explains, short of revealing critical vulnerabilities, officials have to reveal enough details about what studies are being conducted and why they are being done to reassure the public, and U.S. allies, that NBACC is not engaging in offensive work. Keeping threat assessment activities to a bare minimum, Pearson says, would be effective in reassuring allies, as would independent oversight of the NBACC programs. Scientists could play an important and effective role in increasing transparency and easing compliance concerns. They could act as goodwill ambassadors—breaking down barriers to understanding or reducing misunderstandings—by collaborating on some biodefense studies with their counterparts in Britain, France, Israel, and Russia. Former assistant D H S secretary Albright says, "There is obviously a balance between the need for a process that could reasonably be expected to assure other governments that the U.S. is not pursuing a threatening bioweapon capability, and the need to carry out our responsibility to protect our military forces and the public by assessing and countering the threat." Furthermore, he says, "What is important is to ensure compliance with stated policy, which is to not engage in programs aimed at fielding biological weapons." Albright's comment begs the question: Where in the treaty is "fielding" stated? The treaty bars the development of bioC&EN
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GOVERNMENT & POLICY weapons, and development of a weapon comes many steps before fielding it is even possible. At a recent interagency review of NBACC's programs, it became clear that NBACC did not yet have a tight strategic plan with well-articulated research priorities. "They're not there yet, but they're getting there," says a government
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program manager who attended. "I think they need help with appreciating what types of research should be undertaken in light of what the possible perceptions of that research might be," he says. "They need to ask whether the research is important enough to risk potentially highly negative perceptions." On the issue of compliance oversight, Parker says DHS/NBACC "coordinates, works with the Department of State," and "has briefed the National Security Council [NSC} on the treaty compliance processes we are putting in place" for all DHS biodefense programs. The compliance process for NBACC, he says, "is being modeled on the Defense Department's model," which is entirely an internal process. A government source says DHS's compliance office is being established in its Office of Inspector General. Former Pentagon officials who were involved with that department's compliance mechanism are now, as part of the contracting firm BAI, setting up DHS's compliance office. "It is not sufficient for DHS to conduct its own compliance assessments. Independent oversight by a qualified body that might include National Academy of Sciences (NAS) members is essential," insists Elisa D. Harris, a senior research scholar at the University of Maryland's Center for International & Security Studies and former staff member on the Clinton Administration's NSC. T h e r e is now no governmentwide treaty compliance review process at the 32
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NSC level. State Department officials have strongly recommended such a process for projects that might raise compliance concerns. Moodie concurs. "If an agreed-upon set of criteria identifies a particularly sensitive activity, then that activity should be subject to a broader compliance review than just within a single agency" He suggests that "the process could be overseen by NSC and involve some kind of interagency review, with some communication with Congress." "It would be interesting if there was a congressional hearing on N B A C C research," Moodie notes. The challenge, as he sees it, is how Congress would conduct such oversight to ensure that "the program is on target, treaty compliant, cost-effective, and addresses genuine problems." Parker points to presentations at international forums as one means DHS is using to spread the word on DHS's compliance process. "We had someone from our staff at the experts meeting on the codes of conduct on the treaty who, at least, gave an overview of NBACC programs and described the compliance process we are putting in place," he says. Mark Rosen, from DHS's Inspector General's Office, briefed that experts meeting, which was held in Geneva, on his department's compliance efforts, in a general way. For the most part, Pearson, who attended the meeting, says, "Rosen's presentation was fairly boilerplate, explaining what NBACC is and that its work will be treaty compliant." As related by Pearson, Rosen also said DHS was looking to NAS to provide technical and ethical reviews of the work NBACC will be doing. Indeed, at DHS's request, NAS has established the standing Committee on Biodefense Analysis & Countermeasures. The panel will advise DHS on technical issues but will neither make recommendations nor issue reports. Instead, it will act as a steering committee for coordinating specific studies undertaken by subcommittees that will issue reports. The committee held its first meeting in mid-July to hear from NBACC officials and from outside experts, including Epstein, Harris, and O'Toole. It has no established agenda as yet. DHS is also involved with another com-
mittee, the National Science Advisory Board on Biosecurity, which held its first meeting this June. Established at the recommendation of a NAS committee on biotechnology research in the age of terrorism, this board will offer guidance for oversight and publication of federally funded dual-use research. It will not review classified research and so may not consider much of NBACC's work. On the matters of transparency and compliance, McCarthy says, "we work closely with State Department officials" and have had, at their request, "several meetings with individual nations" about "projects {NBACC is doing} and why we are doing them."These meetings, she says, should "increase the confidence among others that {defense} is the motivation of our work." A government official familiar with DHS/State Department interactions says the State Department has had a number of meetings with D H S staff members, some related to the Geneva experts meeting, others more generally about the plans for NBACC. But to say the two agencies are working together closely is a stretch, the official says. DHS has not formally asked the State Department for its views on the types of projects that would raise treaty compliance problems. State Department officials have, however, on an informal basis, cited two that would raise serious concerns about conformity with treaty requirements. These are projects involving aerosolization of CDC's select agents and modification of agents to make them more hazardous. OVER THE MONTHS, government sources say, DHS has grudgingly become more open about what it is doing now and what it plans to do in the future. And the recent interagency review of NBACC sensitized DHS officials—if they weren't already by the Korch controversy—to the importance of perception, says the government program manager. "I don't believe NBACC is charging blindly over the line" of compliance, Epstein says. NBACC officials, he says, "are aware of certain concerns they and the government need to think through. And they are aware of the importance of oversight measures." But Parker is leaving. McCarthy is restructuring NBACC's parent organization, O R D . So whether this awareness translates into programs and oversight that allay the concerns of U.S. allies and arms control and legal experts remains to be seen. • W W W . C E N - O N L I N E.ORG
